Improving Patient Memory for Treatment

Sponsor
University of California, Berkeley (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05668481
Collaborator
(none)
80
1
2
7
11.4

Study Details

Study Description

Brief Summary

The empirical question to be addressed is: What types of memory support are most potent for patients who are experiencing a mild cognitive impairment (MCI) relative to non-MCI patients?

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)
N/A

Detailed Description

People experiencing mild cognitive impairment (MCI) may benefit from adding memory support to treatment-as-usual. Adding memory support may be an innovative way to improve patient memory for treatment, adherence to treatment and outcome.

The key question is: What types of memory support are most potent for MCI patients relative to non-MCI patients?

The aim of the proposed research is to compare the effectiveness of constructive vs. non-constructive memory supports for people who are experiencing MCI compared to people who are not experiencing MCI.

Hypotheses:
  1. Overall recall of the content of treatment will be lower in the MCI group relative to the non-MCI group.

  2. On the one hand, we have evidence from our prior research that constructive memory support is more potent relative to non-constructive memory support. But this research was conducted with adults who did not have MCI. On the other hand, because constructive memory support is more complex to understand, non-constructive memory support may be more effective for MCI patients.

The outcomes are: (1) patient learning behavior coded from a video of the treatment sessions and (2) patient memory for the content of the prior treatment session. We will also collect ratings of the acceptability of the memory supports that are delivered.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will be randomized to receive constructive memory supports in Session 1 OR to receive non-constructive memory supports in Session 1. In Session 2, participants will receive the type of memory support they did not receive in Session 1. In other words, if a participant received constructive memory support in Session 1, in Session 2 they will receive non-constructive memory support. And if a participant received non-constructive memory support in Session 1, in Session 2 they will receive constructive memory support. This cross-over design was adopted to increase the number of observations of the constructive and non-constructive memory support.Participants will be randomized to receive constructive memory supports in Session 1 OR to receive non-constructive memory supports in Session 1. In Session 2, participants will receive the type of memory support they did not receive in Session 1. In other words, if a participant received constructive memory support in Session 1, in Session 2 they will receive non-constructive memory support. And if a participant received non-constructive memory support in Session 1, in Session 2 they will receive constructive memory support. This cross-over design was adopted to increase the number of observations of the constructive and non-constructive memory support.
Masking:
Single (Participant)
Masking Description:
Participants will not be aware that they are receiving constructive memory support in one session and non-constructive memory support in the next session
Primary Purpose:
Treatment
Official Title:
Improving Memory for Treatment for Patients Experiencing Mild Cognitive Impairment: Are Constructive or Non-constructive Memory Supports More Helpful?
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Constructive memory support

Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver constructive memory supports.

Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)
TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.

Active Comparator: Non-constructive memory support

Participants will watch videos of a sleep expert delivering treatment components from the Transdiagnostic Sleep and Circadian Intervention (TranS-C). After each video, a team member will deliver non-constructive memory supports.

Behavioral: Transdiagnostic sleep and circadian intervention (TranS-C)
TranS-C is a psychosocial treatment that helps people who have sleep and circadian problems to improve their sleep health.

Outcome Measures

Primary Outcome Measures

  1. Change on the free recall task to assess outcome for constructive memory support [Delivered two times: At the session in which constructive memory supports were used (baseline) and 1 week later. AND at the end of the session in which non-constructive memory supports were used and 1 week later.]

    Assesses patient memory for treatment

  2. Change on the free recall task to assess outcome for non-constructive memory support [Delivered two times: At the end of the session in which non-constructive memory supports were used (baseline) and 1 week later.]

    Assesses patient memory for treatment

  3. Learning behavior exhibited by the patient during the delivery of constructive memory support [One time point: During the treatment session that constructive memory support was delivered]

    Coded from video tapes of the treatment session in which constructive memory support was delivered

  4. Learning behavior exhibited by the patient during the delivery of non-constructive memory support [One time point: During the treatment session in which non-constructive memory support was delivered]

    Coded from video tapes of the treatment session in which non-constructive memory support was delivered

Secondary Outcome Measures

  1. Acceptability of constructive memory support [One time point: At the end of the treatment session in which constructive memory support was delivered]

    Participants will be asked to rate the "How acceptable were the memory supports we asked you through this session?" The participant will then provide a rating from "1" Not at all acceptable to "9" Very acceptable.

Other Outcome Measures

  1. PROMIS-Sleep Disturbance [At baseline]

    Assesses perceived functional impairments related to sleep problems using a self-report questionnaire. The minimum value is 8. The maximum value is 40. Higher scores mean more sleep disturbance (worse outcome).

  2. PROMIS-Sleep-related impairment [At baseline]

    Assesses perceived functional impairments related to sleep problems in a self-report questionnaire. The minimum value is 16. The maximum value is 80. Higher scores mean more sleep related problems (worse outcome).

  3. British Columbia Cognitive Complaints Inventory [At baseline]

    Assessed perceived cognitive difficulties, scale consists of 6 items. Scores can range from 0-18 with higher scores indicating higher levels of perceived cognitive difficulties

  4. Cognitive Failures Questionnaire [At baseline]

    Used to assess the frequency with which people experienced cognitive failures. Scores range from 0-100, with higher scores indicating higher levels of cognitive failures.

  5. Montreal Cognitive Assessment [At baseline]

    An assessment of cognitive functioning

  6. Sleep intake form [At baseline]

    An assessment of the sleep and circadian problems experienced by the participant

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Participants 60 years and older will be recruited.

  2. Fluent in English.

  3. Experiencing some difficulties relating to sleep and circadian functioning and (d) a score of 19-25 on the Montreal Cognitive Assessment (for the MCI group) and score 26-30 on the Montreal Cognitive Assessment (for the non-MCI group) (e) Have a computer to use and an internet connection and (f) be able to attend sessions weekly and on the same day each week.

Exclusion criteria:
  1. Presence of an active and progressive mental or physical illness or neurological degenerative disease;

  2. Night shift work >2 nights per week in the past 3 months;

  3. Not able and willing to participate in and/or complete the assessments and participate in the treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Berkeley Berkeley California United States 94720-1650

Sponsors and Collaborators

  • University of California, Berkeley

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, Berkeley
ClinicalTrials.gov Identifier:
NCT05668481
Other Study ID Numbers:
  • Protocol 2022-12-15881
First Posted:
Dec 29, 2022
Last Update Posted:
Dec 29, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, Berkeley
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 29, 2022